Tumor Response in Hypofractionated Radiotherapy

Neoplasms Clinical Trial

— TRHR  

Official title:

Biomarkers of Tumor Response in Hypofractionated Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02854449
• Other study ID #: 20161022
• Status: Recruiting
• First received: August 1, 2016
• Last updated: April 18, 2018
• Start date: November 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: Peking University First Hospital
• Contact: Bai Yun, Master
• Email: flkmy1[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study will follow-up different immune cell populations in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of Local Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.

Description:

• Patient information and collection of a signed informed consent form

• Clinical data collection

• Blood samples of 5 mL:

1. after registration, prior to the first fraction of radiotherapy

2. during radiotherapy sessions

3. one month, 3 months after the last radiotherapy session

• Storage of the blood samples at ambient temperature

• Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis

• Destruction of the samples at the end of the analysis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient requiring a hypofractionated irradiation;

• pathologically confirmed Unspecified Adult Solid Tumor

• Age = 18 years old

• KPS=70

• Signed written informed consent.

Exclusion Criteria:

• Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,

• Pregnant or breastfeeding woman,

• Patient under guardianship or tutorship.

Related Conditions & MeSH terms

• Neoplasms

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of immune cells	The primary endpoint is the change of the percentage of immune cells before, during and after radiotherapy	prior to the first fraction of radiotherapy;14(±2) days from the begining of RT; the day (±2) of the last radiotherapy sessions ;one month, 3 months after the last radiotherapy session
Secondary	Local control	Local control of radiotherapy will be assessed based on Response Evaluation Criteria in Solid Tumors(RECIST)1.1	3 months
Secondary	Acute and Late toxicities	Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAEv4.0).	3 months